Pfizer, Arvinas breast cancer therapy approved by the FDA

[US Food and Drug Administration (FDA)]

The U.S. Food and Drug Administration on Friday approved vepdegestrant, a breast cancer therapy developed by Pfizer (PFE [https://seekingalpha.com/symbol/PFE]) and Arvinas (ARVN [https://seekingalpha.com/symbol/ARVN]) under the brand name Veppanu.

Accordingly, the once-daily oral therapy will be available in the U.S. as a late-line option for adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer.

With the approval, the FDA also authorized [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vepdegestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast] Guardant360 CDx, a companion diagnostic device developed by Guardant Health (GH [https://seekingalpha.com/symbol/GH]) to identify breast cancer harboring ESR1 mutations.

In August, the FDA accepted a New Drug Application submitted by Arvinas (ARVN [https://seekingalpha.com/symbol/ARVN]) for vepdegestran, assigning June 5, 2026, as the target action date. [https://seekingalpha.com/news/4482865-pfizer-and-arvinas-breast-cancer-therapy-to-be-reviewed-by-fda]

The NDA was backed by data from the companies’ VERITAC-2 Phase 3 clinical trial, which indicated that patients on vepdegestran survived five months without cancer progression compared to 2.1 months for those who received fulvestrant, an established breast cancer drug.

MORE ON PFIZER, ARVINAS

* Pfizer: Why You Should Double Down Into Q1 [https://seekingalpha.com/article/4897344-pfizer-why-you-should-double-down-into-q1]
* Pfizer Could Surprise Again This Earnings Season (Preview) [https://seekingalpha.com/article/4892740-pfizer-could-surprise-again-this-earnings-season-preview]
* Pfizer: Painful Recovery Underway [https://seekingalpha.com/article/4891549-pfizer-painful-recovery-underway]
* FDA said to have named Katherine Szarama as acting CBER chief [https://seekingalpha.com/news/4584082-fda-names-katherine-szarama-as-acting-cber-chief]
* Pfizer posts late-stage trial win for multiple myeloma therapy Elrexfio [https://seekingalpha.com/news/4581702-pfizer-posts-trial-win-multiple-myeloma-drug]